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Safety and Efficacy Study of Association Between Tretinoin and Clindamycin on the Treatment of Acne Mild and Moderate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00838812
Recruitment Status : Completed
First Posted : February 6, 2009
Last Update Posted : May 25, 2010
Information provided by:
Igefarma Laboratorios S.A.

Brief Summary:
The purpose of this study is to determine the safety and efficacy of association between tretinoin and clindamycin phosphate on the treatment of acne vulgaris mild and moderate.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: application of the topic gel Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Monocentric Study, Prospective, Open and Non Controlled for to Evaluate the Effectiveness, and Tolerability the Safety of Association of Clindamycin Phosphate 1.2% and Tretinoin 0,025% in the Treatment of Acne Vulgaris Mild to Moderate, When Used Once Daily for 12 Weeks.
Study Start Date : March 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : April 2010

Arm Intervention/treatment
clindamicin and tretinoin gel Drug: application of the topic gel
Clindamycin Phosphate 1,2% and tretinoin 0,025% gel once daily at night 12 weeks.

Primary Outcome Measures :
  1. Evaluation of the efficacy, through number of lesions, and tolerability of the product. [ Time Frame: three months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Individuals of both sexes with age greater than or equal to 12 years
  • Subjects diagnosed with acne vulgaris in the face, except for the nasal area, range from mild to moderate, with the following requirements.

    • Mild acne = presence of fewer than 20 comedones or less than 15 lesions, inflammatory lesions or a total of less than 30 injuries.
    • Moderate acne = presence of 20 the 100 comedones or of 15 the 50 inflamatory lesions or a total of 30 the 125 lesions, with not more than lesions small nodule until 5,0 mm.
  • Ensure that the existing injuries were not submitted any treatment for acne, topical or systemic, within the last 30 days.
  • Be able to properly follow the determinations of the Protocol.
  • Has provided a written voluntary consent to participate in the study, by signing the informed consent, before being subjected to any procedure.
  • Under 18 years old, be accompanied by legal guardian in the process of obtaining the informed consent.
  • Be mentally able to provide consent and be fulfilling all the requirements of the study.

Exclusion Criteria:

  • Pregnant women or in periods of lactation.
  • Women of childbearing age and sexual activity with not using safe contraceptive method, such as oral contraceptives, implantable, injectable or intra-uterine, introduced for at least 120 days.
  • Women who are using oral contraceptives containing the hormone combination for acetate ciprosterone and etinolestradiol, association of drospirenone and ethinyl estradiol, or desogestrel.
  • Clinical evidence or history of immunodeficiency.
  • Any use of immunosuppressive drug and/or immunomodulating over the past 3 months, topical or systemic.
  • Concurrent use of fotossentetizadores, neuromuscular blockers, medications that exacerbate the acne, blockers (filters) with solar alcoholic vehicle, spironolactone, flutamide or zinc salts.
  • Prior use of systemic retinoid.
  • Presence of acne medication and/or cosmetic.
  • History of systemic metabolic disorder that can interfere with the integrity of the skin.
  • History of inflammatory disease, intestinal or regional enteritis and/or symptoms similar.
  • History of joy to any of the components of the formula (active principle or carrier).
  • History of abuse of alcohol and/or illegal drugs.
  • History of non-adherence to medical treatment earlier.
  • Any clinical observation made by the investigator that prohibits participation in the study of the subject.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00838812

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Lal Clinica
Valinhos, São Paulo, Brazil, 13276-245
Sponsors and Collaborators
Igefarma Laboratorios S.A.
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Responsible Party: Dra. Rosa Maria Scavarelli, I Identifier: NCT00838812    
Other Study ID Numbers: IGF 03-42008
First Posted: February 6, 2009    Key Record Dates
Last Update Posted: May 25, 2010
Last Verified: May 2010
Keywords provided by Igefarma Laboratorios S.A.:
acne vulgaris
Acne vulgaris mild to moderate
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases